Collplant Biotechnologies Ltd (CLGN) 2023 Q2 法說會逐字稿

Welcome to the CollPlant Biotechnologies investor conference call to discuss financial results for the second quarter of 2023 and corporate updates. (Operator Instructions) As a reminder, this conference is being recorded.

歡迎參加 CollPlant Biotechnologies 投資者電話會議，討論 2023 年第二季的財務業績和公司最新動態。 （操作員指示）謹此提醒，本次會議正在錄製中。

I would now like to turn the call over to your host, Dory Kurowski of LifeSci Advisors. Please go ahead.

現在我想將電話轉給主持人、LifeSci Advisors 的 Dory Kurowski。請繼續。

I would like to welcome everyone to CollPlant Biotechnologies financial results conference call for the second quarter ended June 30, 2023 and corporate business update. With us on the call today from CollPlant are Yehiel Tal, Chief Executive Officer, who will provide an overview of the company's program and forthcoming updates; and Eran Rotem, Deputy CEO and Chief Financial Officer, who will provide a summary of CollPlant's financial results for the second quarter ended June 30, 2023.

我謹歡迎大家參加 CollPlant Biotechnologies 截至 2023 年 6 月 30 日的第二季財務業績電話會議和公司業務更新。今天與我們一起參加 CollPlant 電話會議的是執行長 Yehiel Tal，他將概述公司的計劃和即將發布的最新動態；副執行長兼財務長 Eran Rotem 將提供 CollPlant 截至 2023 年 6 月 30 日的第二季財務業績摘要。

Before we get started, I would like to remind everyone that statements made on this conference call may include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in Risk Factors section of CollPlant's filings with the Securities and Exchange Commission. These filings can be found at www.sec.gov or on CollPlant's website at www.collplant.com.

在我們開始之前，我想提醒大家，本次電話會議的陳述可能包含前瞻性陳述。由於各種風險、不確定性和其他因素，包括CollPlant 向美國證券交易委員會提交的文件的風險因素部分中列出的因素，實際事件或結果可能與任何前瞻性陳述中明示或暗示的事件或結果存在重大差異。這些文件可在 www.sec.gov 或 CollPlant 網站 www.collplant.com 上找到。

In addition, any forward-looking statements made on this call represent CollPlant's views only as of today, August 24, 2023, and should not be relied upon as representing the company's views as of any subsequent date. CollPlant management specifically disclaims any obligation to update or revise any of these forward-looking statements.

此外，本次電話會議中所做的任何前瞻性陳述僅代表 CollPlant 截至今天（2023 年 8 月 24 日）的觀點，不應被視為代表該公司截至任何後續日期的觀點。 CollPlant 管理階層明確表示不承擔更新或修改任何這些前瞻性陳述的義務。

Finally, corporate management will refer to certain financial measures not reported in accordance with GAAP on this call. You can find reconciliations of these non-financial GAAP measures to the GAAP financial measures in the earnings press release that CollPlant published earlier today and which is available on CollPlant's website at ir.collplant.com.

最後，公司管理階層將在本次電話會議上提及未依照 GAAP 報告的某些財務指標。您可以在 CollPlant 今天稍早發布的收益新聞稿中找到這些非財務 GAAP 指標與 GAAP 財務指標的調整表，該新聞稿可在 CollPlant 網站 ir.collplant.com 上取得。

With that, let me turn the call over to Yehiel Tal, Chief Executive Officer of CollPlant Biotechnologies. Please go ahead, sir.

接下來，讓我將電話轉給 CollPlant Biotechnologies 執行長 Yehiel Tal。請繼續，先生。

Good morning, everyone. We are very pleased to have you join us today on CollPlant investor conference call to discuss our second-quarter 2023 financial results and corporate developments.

大家，早安。我們很高興您今天參加 CollPlant 投資者電話會議，討論我們 2023 年第二季的財務表現和企業發展。

CollPlant is developing collagen technology and regenerative medicine products to improve and prolong lives. We are committed to becoming the leaders in regenerative medicine and supporting more sustainable ecosystems that benefit all stakeholders, including patients, our shareholders, and our employees, as well as providing innovation to the life science industry.

CollPlant 正在開發膠原蛋白技術和再生醫學產品，以改善和延長生命。我們致力於成為再生醫學領域的領導者，支持更永續的生態系統，使所有利害關係人受益，包括病患、我們的股東和員工，並為生命科學產業提供創新。

And now, on to our development programs. Our goal is to create advanced organ and tissue solutions through use of our novel, proprietary, non-animal-derived recombinant human collagen technology that we are applying to novel medical and aesthetic products. Our rhCollagen is an advancement both due to its regenerative properties and also because it is xenotissue-free, which means it is not derived from animals. Instead, CollPlant produces this recombinant human collagen in genetically engineered tobacco plants.

現在，我們的發展計劃。我們的目標是透過使用我們新穎的、專有的、非動物性重組人類膠原蛋白技術來創建先進的器官和組織解決方案，並將其應用於新穎的醫療和美容產品。我們的 rhCollagen 是一項進步，不僅因為它具有再生特性，而且因為它不含異種組織，這意味著它不是來自動物。相反，CollPlant 在基因工程菸草植物中生產這種重組人類膠原蛋白。

In the second quarter, we announced the achievement of a very important company milestone related to the dermal and soft tissue filler product candidate in development with our partner AbbVie. This product is in the clinical phase, and the achievement of the milestone triggered a $10 million payment to CollPlant. CollPlant has the potential to receive additional milestone payments, as well as future royalties, in accordance with its long-term collaboration with AbbVie for its dermal filler.

在第二季度，我們宣布實現了一個非常重要的公司里程碑，該里程碑與我們與合作夥伴艾伯維 (AbbVie) 共同開發的真皮和軟組織填充劑產品候選產品有關。該產品正處於臨床階段，這一里程碑的實現觸發了向 CollPlant 支付 1000 萬美元的付款。根據與艾伯維（AbbVie）在真皮填充劑方面的長期合作，CollPlant 有可能獲得額外的里程碑付款以及未來的特許權使用費。

The dermal filler product candidate with AbbVie has a potential to create a paradigm shift in the fillers market since it would provide regenerative properties for new skin growth in addition to tissue filling. This program is our top focus, and as planned, AbbVie continues to advance the filler program.

艾伯維的真皮填充劑候選產品有可能在填充劑市場中創造範式轉變，因為除了組織填充之外，它還可以為新皮膚的生長提供再生特性。該計劃是我們的首要關注點，按照計劃，艾伯維將繼續推進填充劑計劃。

Our next leading program is our regenerative breast implants. One of our upcoming milestones will be initiating, by year-end, a second large animal study to evaluate our regenerative breast implants. We have already established the trial infrastructure and look forward to providing an update as soon as we conclude the study. This study follows the completion of our first large animal study, the result of which were announced in January of this year.

我們的下一個領先項目是再生乳房植入物。我們即將到來的里程碑之一將是在年底前啟動第二項大型動物研究，以評估我們的再生乳房植入物。我們已經建立了試驗基礎設施，並期待在研究結束後立即提供最新資訊。這項研究是在我們完成第一項大型動物研究之後進行的，該研究的結果於今年 1 月公佈。

That preclinical study demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and no vascular networks within the implants, with, importantly, no adverse events reported. CollPlant's breast implants that are comprised of its proprietary plant-derived rhCollagen and other biomaterials are expected to regenerate breast tissue without eliciting immune response, and thus may provide a revolutionary alternative for aesthetic and reconstructive procedures, with the reconstructive feature of our recombinant human collagen being key for breast cancer patients during the post-mastectomy period.

這項臨床前研究證明了三個月後組織再生的進展階段，突顯成熟結締組織的形成和植入物內沒有血管網絡，重要的是，沒有報告不良事件。 CollPlant 的乳房植入物由其專有的植物源性rhCollagen 和其他生物材料組成，預計能夠在不引起免疫反應的情況下再生乳房組織，因此可能為美容和重建手術提供革命性的替代方案，因為我們的重組人類膠原蛋白的重建功能是乳癌患者在乳房切除術後的關鍵時期。

In the second quarter, we announced a joint development and commercialization collaborative agreement with Stratasys, the world leader in additive manufacturing and leader in 3D printing technology. With Stratasys, we are collaborating on the development of a printing solution to biofabricate human tissues and organs. Initially, our collaborative project will focus on the development of an industrial-scale solution for CollPlant's regenerative breast implants.

第二季度，我們宣布與積層製造領域的全球領導者和 3D 列印技術的領導者 Stratasys 達成共同開發和商業化合作協議。我們正在與 Stratasys 合作開發生物製造人體組織和器官的列印解決方案。最初，我們的合作計畫將專注於為 CollPlant 的再生乳房植入物開發工業規模的解決方案。

This collaboration between the two companies combines the Stratasys DLP 3D printer that is utilizing a unique programmable photopolymerization, P3 technology, together with CollPlant's state-of-the-art rhCollagen-based bioinks and 3D bioprinting capabilities. Having an effective solution for scale-up of our regenerative breast implants will be important to support related clinical trials and commercialization.

兩家公司之間的合作將 Stratasys DLP 3D 列印機（採用獨特的可編程光聚合 P3 技術）與 CollPlant 最先進的基於 rhCollagen 的生物墨水和 3D 生物列印功能結合在一起。擁有有效的解決方案來擴大再生乳房植入物的規模對於支持相關的臨床試驗和商業化非常重要。

By combining Stratasys and CollPlant's technologies, the companies will be able to print scaffolds that accurately mimic the physical properties of human tissues and organs that are expected to have high-resolution scalability and reproducibility. The combined proprietary technologies will allow for 3D tissue and organ fabrication. It also possesses differentiated regenerative properties. Under the agreement, both companies have also agreed to cross-promote each other's bioprinted products.

透過結合 Stratasys 和 CollPlant 的技術，兩家公司將能夠列印精確模仿人體組織和器官物理特性的支架，預計這些支架將具有高解析度的可擴展性和可重複性。結合的專有技術將允許 3D 組織和器官製造。它還具有差異化的再生特性。根據協議，兩家公司也同意交叉推廣對方的生物列印產品。

Here, you can see an example of a breast implant that was printed with Stratasys DLP printer, utilizing its P3 technology in combination with CollPlant's collagen-based bioinks. It is our objective that our bioinks become the gold standard for use in fabricating tissues and organs. Collaborations, such as the one formed with Stratasys, are therefore important to us to allow the opportunity to determine which of our different types of bioinks are best suited for use with different advanced technologies so that we may refine the production of different organs or tissues that we are fabricating in accordance with optimal properties.

在這裡，您可以看到使用 Stratasys DLP 印表機列印的乳房植入物的範例，該印表機利用其 P3 技術與 CollPlant 的基於膠原蛋白的生物墨水相結合。我們的目標是使我們的生物墨水成為製造組織和器官的黃金標準。因此，與 Stratasys 等合作對我們來說非常重要，讓我們有機會確定哪些不同類型的生物墨水最適合與不同的先進技術一起使用，以便我們可以改進不同器官或組織的生產，我們按照最佳性能進行製造。

As we have mentioned previously, our strategy is to utilize different printing technologies to serve different indications being sought, and therefore, we have collaborations with multiple partners. For example, we would need to have use of multiple materials or needs to be able to print constructs with very small features for products such as gut-on-a-chip and lung-on-a-chip tissue models.

正如我們之前提到的，我們的策略是利用不同的印刷技術來滿足不同的需求，因此我們與多個合作夥伴進行了合作。例如，我們需要使用多種材料，或者需要能夠為諸如腸道晶片和肺晶片組織模型等產品列印具有非常小的特徵的結構。

The bioprinting aspect of our business has applicability in multiple areas such as cardiology, ophthalmology, and orthopedics. As such, CollPlant looks to produce a wide range of organs and tissues and remains engaged in partnering discussions with several industry leaders and academic institutions interested in the company's rhCollagen technology and expertise in 3D bioprinting to develop therapeutics and medical applications.

我們業務的生物列印方面適用於心臟病學、眼科和骨科等多個領域。因此，CollPlant 希望生產各種器官和組織，並繼續與對該公司的 rhCollagen 技術和 3D 生物列印專業知識感興趣的多家行業領導者和學術機構進行合作討論，以開發治療和醫療應用。

But back to our breast implants that are currently in development. CollPlant implants are designed to regenerate breast tissue without eliciting immune response and, therefore, have the potential to become a revolutionary alternative for both aesthetic and reconstructive procedures, including post-mastectomy, for cancer patients.

回到我們目前正在開發的乳房植入物。 CollPlant 植入物的設計目的是在不引起免疫反應的情況下再生乳房組織，因此有可能成為癌症患者美容和重建手術（包括乳房切除術後）的革命性替代方案。

According to the U.S. Food and Drug Administration, approximately 350,000 Americans have reported adverse events involving breast implants between 2009 and 2019. Reports range from autoimmune symptoms to breast implant-associated anaplastic large cell lymphoma. The additional safety and efficacy data that we will generate from this upcoming large animal study will be used to optimize the development of the regenerative implant and are important to support future regulatory submissions and clinical studies. We look forward to reporting results from the study next year.

根據美國食品藥物管理局的數據，2009 年至2019 年間，大約有35 萬美國人報告了涉及乳房植入物的不良事件。報告範圍從自體免疫症狀到與乳房植入物相關的間變性大細胞淋巴瘤。我們將從這項即將進行的大型動物研究中產生的額外安全性和有效性數據將用於優化再生植入物的開發，並且對於支持未來的監管提交和臨床研究非常重要。我們期待明年報告研究的結果。

Lastly, we will mention our gut-on-a-chip program, which is an area where we have the opportunity to disrupt the options that have traditionally existed in life sciences. CollPlant is developing, together with Tel Aviv University and Shiba Medical Center, a 3D bioprinted model that is designed to emulate the tissue of the human intestine to assay drug response metabolism and other factors in humans. A device such as this would allow medical professionals to identify drug targets and personalize therapeutic responses that could lead to improved patient outcomes to provide a predictive personalized platform.

最後，我們將提到我們的晶片腸道項目，在這個領域，我們有機會顛覆生命科學中傳統存在的選擇。 CollPlant 正在與特拉維夫大學和 Shiba 醫學中心合作開發 3D 生物列印模型，旨在模擬人體腸道組織，以分析人體的藥物反應代謝和其他因素。諸如此類的設備將允許醫療專業人員識別藥物標靶並個性化治療反應，從而改善患者的治療結果，從而提供預測性個人化平台。

Tissue-on-a-chip devices are typically comprised of chambers or channels that recapitulate the distinct compartments and structures of the targeted organ. Our system being developed enhances the physiological relevance of the human gut to provide a predictive personalized platform.

晶片組織裝置通常由室或通道組成，概括了目標器官的不同區室和結構。我們正在開發的系統增強了人類腸道的生理相關性，以提供預測性個人化平台。

CollPlant mimics the gut structure by 3D printing the gut tissue geometry in high resolution using its unique rhCollagen-based bioink formulation. The system then can be used to evaluate therapy response in patients suffering from ulcerative colitis. The multi-array chip design is intended to support high-throughput therapy screening.

CollPlant 使用其獨特的基於 rhCollagen 的生物墨水配方，透過高解析度 3D 列印腸道組織幾何形狀來模擬腸道結構。該系統隨後可用於評估潰瘍性結腸炎患者的治療反應。多陣列晶片設計旨在支援高通量治療篩選。

Recently, CollPlant team managed to successfully grow epithelial cells on the 3D printed scaffolds. In various areas of personalized medicine, we expect that this approach could be groundbreaking improvement over the existing use of animal models for drug developments. This will be a sustainable means for drug development and patient diagnosis without the use of animals. And we remind you, this program is also very much in line with our ESG initiatives.

最近，CollPlant團隊成功在3D列印支架上生長上皮細胞。在個人化醫療的各個領域，我們預計這種方法可以對現有的藥物開發動物模型的使用進行突破性的改進。這將是一種不使用動物的藥物開發和患者診斷的可持續手段。我們提醒您，該計劃也非常符合我們的 ESG 措施。

Should the gut-on-a-chip receive regulatory approval, CollPlant has exclusive rights to commercialize the product. We hope to provide an update on the next steps for this program by the end of the year. As mentioned, CollPlant remains engaged in partnering discussions with several additional industry leaders interested in the CollPlant's technology and expertise in 3D bioprinting for therapeutic and medical applications.

如果晶片腸道獲得監管部門的批准，CollPlant 擁有將該產品商業化的獨家權利。我們希望在今年年底之前提供有關該計劃後續步驟的最新資訊。如前所述，CollPlant 仍在與其他幾家對 CollPlant 在治療和醫療應用 3D 生物列印方面的技術和專業知識感興趣的行業領導者進行合作討論。

In line with being part of this mission to support a sustainable ecosystems, we wanted to highlight that we have made commitment to advance our ESG, or environmental, social, and governance initiatives. Our first step to do this, which is implemented in the second quarter, was hiring a dedicated expert to lead our ESG effort. Our ESG manager is responsible for identifying CollPlant's strengths in the areas of ESG that are already in line with our mission.

為了履行支持永續生態系統這項使命，我們想強調，我們已承諾推動我們的 ESG（環境、社會和治理措施）。我們在第二季度實施的第一步是聘請一位專門的專家來領導我們的 ESG 工作。我們的 ESG 經理負責確定 CollPlant 在 ESG 領域的優勢，這些優勢已經符合我們的使命。

Importantly, she will lead with communicating these practices to business partners and to the public. Being able to communicate our initiatives was a mandate for us after we conducted a formal analysis of our current operations and identified what we are doing correctly or where we can further improve. We look forward to working on this initiative and being able to communicate our ESG efforts, both as they relate to our company mission as well as they relate to our day-to-day operations and company values and culture.

重要的是，她將領導者向業務合作夥伴和公眾傳達這些做法。在我們對當前營運進行正式分析並確定我們正在做的事情或可以進一步改進的地方之後，能夠傳達我們的舉措是我們的一項任務。我們期待致力於這項舉措，並能夠傳達我們的 ESG 努力，因為它們既與我們的公司使命相關，也與我們的日常營運以及公司價值觀和文化相關。

This concludes my initial remarks about our very promising programs. Now, I will turn the call over to our Deputy CEO and Chief Financial Officer, Eran Rotem, to provide a recap of the financial results. Eran?

我對我們非常有前途的計劃的初步評論到此結束。現在，我將把電話轉給我們的副執行長兼財務長 Eran Rotem，以概述財務業績。埃蘭？

Thank you, Yehiel. Good morning, everyone. I will now review our financial results for the three-month period ending June 30, 2023.

謝謝你，葉希爾。大家，早安。我現在將回顧我們截至 2023 年 6 月 30 日的三個月期間的財務表現。

This quarter, we saw a significant increase in revenues versus last year. For the second quarter ended June 30, 2023, GAAP revenues were $10.2 million, compared to $66,000 in the second quarter ended June 30, 2022. Revenues increase by $10.1 million is mainly related to the achievement of a milestone with respect to the AbbVie agreement, which triggered a $10 million payment.

本季度，我們的收入與去年相比顯著增加。截至2023年6月30日的第二季度，公認會計準則收入為1,020萬美元，而截至2022年6月30日的第二季度收入為66,000美元。收入增加1,010萬美元主要與艾伯維協議取得的里程碑有關，這引發了 1000 萬美元的付款。

Revenues from this quarter included also income from sales of CollPlant's bioink and rhCollagen that are serving different companies and academic institutes in the development of 3D bioprinting products and other products. As stated previously, according to the agreement with AbbVie, CollPlant is also eligible to receive up to an additional $26 million in milestone payments for the dermal filler product, as well as royalty payments and fees for the manufacture and supply of rhCollagen once the product will be in the commercial phase.

本季的收入還包括 CollPlant 的生物墨水和 rhCollagen 的銷售收入，這些產品為不同公司和學術機構的 3D 生物列印產品和其他產品的開發提供服務。如前所述，根據與艾伯維的協議，CollPlant 還有資格獲得高達 2600 萬美元的真皮填充劑產品里程碑付款，以及特許權使用費以及 rhCollagen 生產和供應費用。處於商用階段。

GAAP cost of revenues for the second quarter ended June 30, 2023 was $615,000, compared to $43,000 in the second quarter of 2022. Cost of revenues includes mainly the cost of the company's rhCollagen-based products and royalties to the Israel Innovation Authority, or IIA, for the company's sales.

截至2023 年6 月30 日的第二季的GAAP 收入成本為615,000 美元，而2022 年第二季為43,000 美元。收入成本主要包括該公司基於rhCollagen 的產品的成本以及以色列創新局(IIA) 的特許權使用費，用於公司的銷售。

The gross profit in the second quarter of '23 was positively affected by the achievement of the milestone with AbbVie. And GAAP gross profit accumulated to $9.6 million compared to gross profit of $23,000 in the second quarter of 2022.

23 年第二季的毛利受到與艾伯維 (AbbVie) 達成的里程碑的正面影響。 GAAP 毛利累計達到 960 萬美元，而 2022 年第二季毛利為 23,000 美元。

GAAP operating expenses for the second quarter of 2023 were $3.9 million, a 7% decrease compared to $4.2 million for the second quarter of 2022. Operating expenses include research and development, or R&D, expenses and sales general and administrative, or SG&A, expenses.

2023 年第二季的 GAAP 營運費用為 390 萬美元，比 2022 年第二季的 420 萬美元下降 7%。營運費用包括研發費用以及銷售一般和管理費用（SG&A）。

R&D expenses related to supporting the company's development efforts in different programs, including the regenerative breast implant and gut-on-a-chip programs. R&D expenses for the second quarter of 2023 and 2022 remained unchanged at $2.6 million.

研發費用與支援公司不同項目的開發工作有關，包括再生乳房植入物和晶片腸道項目。 2023年和2022年第二季的研發費用維持在260萬美元不變。

The GAAP SG&A expenses for the second quarter of 2023 were $1.3 million, a 19% decrease compared to $1.6 million for the second quarter of 2022. The reduction is mainly attributable to salary-related costs for the company's employees.

2023 年第二季的 GAAP SG&A 費用為 130 萬美元，比 2022 年第二季的 160 萬美元減少 19%。減少的主要原因是公司員工的薪資相關成本。

On a non-GAAP basis, the operating expenses for the second quarter of 2023 were $3.6 million, an 8% reduction, compared to $3.9 million for the second quarter of 2022. Non-GAAP measures exclude certain non-cash expenses.

以非公認會計原則計算，2023 年第二季的營運支出為 360 萬美元，較 2022 年第二季的 390 萬美元減少 8%。非公認會計原則指標不包括某些非現金支出。

GAAP financial income, net, for the second quarter of 2023 totaled $85,000, compared to financial expenses, net, of $100,000 in the second quarter of 2022. The increase in financial income, net, in Q2 2023 is attributed mainly to interest received from the company's short-term cash deposits and exchange rate differences.

2023 年第二季的 GAAP 財務收入淨額總計 85,000 美元，而 2022 年第二季的財務費用淨額為 100,000 美元。2023 年第二季財務收入淨額的增加主要歸因於從公司短期現金存款及匯率差異。

GAAP net income for the second quarter of 2023 was $5.8 million, or $0.51 basic income per share, compared to a net loss in Q2 2022 of $4.3 million, or $0.39 basic loss per share. Non-GAAP net income for the second quarter of '23 was $6 million, or $0.53 basic income per share, compared to the second quarter of 2022 that ended with a $4 million loss, or $0.36 basic loss per share.

2023 年第二季的 GAAP 淨利潤為 580 萬美元，即每股基本收入 0.51 美元，而 2022 年第二季的淨虧損為 430 萬美元，即每股基本虧損 0.39 美元。 2023 年第二季的非 GAAP 淨利潤為 600 萬美元，即每股基本收入 0.53 美元，而 2022 年第二季最終虧損 400 萬美元，即每股基本虧損 0.36 美元。

We have maintained a strong cash position and have carefully contained corporate operating expenses. Cash equivalents and restricted cash as of June 30, 2023 were $22.4 million. Note that this amount does not include the $10 million milestone payment which was received from AbbVie in July 2023.

我們保持強勁的現金狀況，並謹慎控制公司營運支出。截至 2023 年 6 月 30 日，現金等價物及限制性現金為 2,240 萬美元。請注意，這筆金額不包括 2023 年 7 月從艾伯維收到的 1,000 萬美元里程碑付款。

A reminder, we have no outstanding debt on our balance sheet.

提醒一下，我們的資產負債表上沒有未償債務。

Cash used in operating activities during the second quarter of 2023 was $3.8 million, compared to $4 million during the second quarter of 2022.

2023 年第二季經營活動使用的現金為 380 萬美元，而 2022 年第二季為 400 萬美元。

Cash provided by financing activities during the second quarter of 2023 was $89,000, compared to no cash from financing activities in second quarter of 2022.

2023 年第二季融資活動提供的現金為 89,000 美元，而 2022 年第二季融資活動則沒有提供現金。

This now concludes the financial summary. Operator, I believe that we can now open the call for questions.

財務摘要到此結束。接線員，我相信我們現在可以開始提問了。

(Operator Instructions) Swayampakula Ramakanth, H.C. Wainwright.

（操作員說明）Swayampakula Ramakanth, H.C.溫賴特。

Thank you. This is RK from H.C. Wainwright. Good morning, folks. A couple of quick questions from me. On the breast implant program, what's the regulatory pathway and what additional studies do you need to do before getting on to the regulatory pathway?

謝謝。我是 H.C. 的 RK。溫賴特。早安，夥計們。我問了幾個簡單的問題。關於乳房植入計劃，監管途徑是什麼？在進入監管途徑之前您還需要做哪些額外的研究？

Hi, RK. Thank you for the question. The regulatory pathway for the breast implant is going to be probably a PMA pathway. We're not sure yet who is going to be the jurisdiction authority, but it looks like it will be a combination of CDRH and CBER. Probably, CBER will be the leading and then CDRH will be a consultancy role for the process.

嗨，RK。感謝你的提問。乳房植入物的調節途徑可能是 PMA 途徑。我們還不確定誰將成為管轄機構，但看起來將是 CDRH 和 CBER 的組合。很可能，CBER 將發揮主導作用，然後 CDRH 將擔任該流程的顧問角色。

Regarding your second question on what other clinical studies will be needed, so first of all, regarding the upcoming study, this upcoming study is a very important one because it is going to focus on, and this is the first time, clinically relevant size implants, and this study is going to check, obviously, safety and efficacy. Also, it is going to be used for verifications of the quality of the tissues that is being regenerated is really a fat tissue as the host tissue.

關於你的第二個問題，即還需要哪些其他臨床研究，首先，關於即將進行的研究，這項即將進行的研究是一項非常重要的研究，因為它將重點關注（這是第一次）臨床相關尺寸的植入物，顯然，這項研究將檢查安全性和有效性。此外，它將用於驗證正在再生的組織是否確實是作為宿主組織的脂肪組織的品質。

We are also going to practice the surgical protocol. The formulation will be selected, the final formulations, and also, the implant design will be optimized. And then this will be the basis for the other studies that will follow, which is going to be a pivotal study. And hopefully, this study will be the last for a clinical study.

我們也將練習手術方案。將選擇配方、最終配方，並且優化植入物設計。這將成為後續其他研究的基礎，這將是一項關鍵研究。希望這項研究將是最後一項臨床研究。

Thank you for that. So when do you think you can start the PMA process? Or can you start it as you're getting through your next animal study?

謝謝你。那麼您認為什麼時候可以開始 PMA 流程？或者您可以在進行下一次動物研究時開始它嗎？

It is, at this point of time, premature for us to come up with time for the PMA study because we need to interface the FDA and we should discuss with them the regulatory pathway and verify the requirements for the clinical study. So we are not there yet. We are trying to conclude this upcoming study first, so we will be in a much better position to know exactly what is going to be the implant in terms of formulation, have a complete surgical procedure in place, and then we'll be in a position to start the discussions and get the inputs from the FDA about the duration of the study and the other requirements.

目前，我們為 PMA 研究安排時間還為時過早，因為我們需要與 FDA 溝通，我們應該與他們討論監管途徑並驗證臨床研究的要求。所以我們還沒到那一步。我們正試圖先結束這項即將進行的研究，這樣我們就能更好地了解植入物的配方，制定完整的手術程序，然後我們將進入一個新的階段。開始討論並從FDA 獲取有關研究持續時間和其他要求的意見。

Okay. Thanks for that. And then on the gut-on-a-chip program, how do you plan to monetize this? Is this going to be a transaction for the platform itself? Or do you think either you or you along with a collaborator can be providing this as a service to the drug developer market?

好的。感謝那。然後在晶片腸道項目上，您打算如何將其貨幣化？這是平臺本身的交易嗎？或者您認為您或您與合作者可以將其作為服務提供給藥物開發商市場嗎？

Thank you for the question. It's a great question. The concept is the following. We will produce the scaffolds as it will mimic the gut tissue, and we will, together with the microfluidic chip and the matrices that we will develop, so we can do a multi-channel kind of testing. We will provide all of this to our collaborator, which should be a CRO that will take the biopsies from the patient, collect the biopsies, and seed the scaffolds and do the testing. So this is the concept.

感謝你的提問。這是一個很好的問題。其概念如下。我們將生產模擬腸道組織的支架，我們將與我們將開發的微流控晶片和基質一起，這樣我們就可以進行多通道測試。我們將把所有這些提供給我們的合作者，該合作者應該是 CRO，將從患者身上獲取活檢、收集活檢、接種支架並進行測試。這就是這個概念。

Okay, thanks. Thanks for taking my questions.

好的謝謝。感謝您回答我的問題。

You're welcome.

不客氣。

[Steve Perry, Perco Industries].

[史蒂夫·佩里，Perco Industries]。

First of all, thank you for taking me in. Great quarter you guys just came in with. My questions are around timing. Just wondering, for the dermal filler market, when does the actual study begin, and what's the timing and length of that study that it's going to take to commercialize that product, if you have any idea? What's your thoughts on that?

首先，感謝你們接納我。你們剛進來的時候很棒。我的問題是關於時間安排的。只是想知道，對於真皮填充劑市場，實際研究何時開始，以及將該產品商業化所需的研究時間和長度是多少，如果您有任何想法？你對此有何看法？

So hi, thanks for the question. This is Eran Rotem. The product is being led by AbbVie and Allergan. This is the product of AbbVie. CollPlant is not dictating the timelines and is not allowed to disclose what -- is not allowed to be disclosed by AbbVie. I'm mentioning that because, usually, companies will disclose it.

嗨，謝謝你的提問。這是伊蘭·羅特姆。該產品由艾伯維（AbbVie）和艾爾建（Allergan）主導。這是艾伯維的產品。 CollPlant 沒有規定時間表，也不允許披露艾伯維 (AbbVie) 不允許披露的內容。我之所以提到這一點，是因為公司通常會透露這一點。

So what we told to the public so far, this is what we are allowed. And we are developing with AbbVie that product, which is in a clinical phase. We are developing that product. If you do the math and look at the publications, it's four years down the road. It means that we are developing it already for years. It's in a clinical phase.

所以到目前為止我們告訴公眾的是，這是我們被允許的。我們正在與艾伯維（AbbVie）一起開發該產品，該產品正處於臨床階段。我們正在開發該產品。如果你計算一下並查看出版物，你會發現已經是四年後的事了。這意味著我們已經開發它多年了。正處於臨床階段。

Beyond that, we are not allowed to say, today, anything. We achieved a milestone. It came with a $10 million check, which means that this program is moving forward. And we keep on saying the sentence, which is, this product is moving according to the plan. So I hope that is a satisfying answer for you.

除此之外，今天我們不能說任何話。我們實現了一個里程碑。它附有一張 1000 萬美元的支票，這意味著該計劃正在向前推進。而我們一直在說這句話，那就是這個產品正在按照計畫進行。所以我希望這對您來說是一個滿意的答案。

No, it is. And so quick question on size of the market as far as dermal fillers go. I've read some different numbers that the worldwide size of the dermal filler market is about $5.5 billion. But I've also read that that can go as high as $9 billion or $10 billion. Where do you think the size of that market is?

不，是的。關於真皮填充劑的市場規模，這是一個簡單的問題。我讀到一些不同的數字，全球真皮填充劑市場規模約為 55 億美元。但我也了解到，這數字可能高達 90 億或 100 億美元。您認為這個市場的規模在哪裡？

So we are familiar with the current number, which is $5.5 billion annual sales globally, and this is based on public research that is out there. We are also familiar with a 10% annual growth. And I think part of the research are talking about what will happen in four or five years from now. And maybe that is where the $9 billion is coming. We are familiar with current global size of $5.5 billion.

我們很熟悉目前的數字，即全球年銷售額 55 億美元，這是基於公開研究的。我們也熟悉10%的年增長率。我認為部分研究正在討論四、五年後會發生什麼事。也許這就是 90 億美元的來源。我們熟悉目前的全球規模為 55 億美元。

Got it. Okay. All right. Those were my questions.

知道了。好的。好的。這些都是我的問題。

And definitely, by the way, Allergan is the major -- a key company that is selling that product. They are selling between $1.5 billion to -- sometimes, they almost reach $2 billion annual sales of the JUVÉDERM product. So they are leading that market.

順便說一句，艾爾建（Allergan）無疑是主要的——一家銷售該產品的主要公司。 JUVäDERM 產品的年銷售額在 15 億美元到有時幾乎達到 20 億美元之間。所以他們正在引領這個市場。

And I don't know if you can disclose this or not, in retrospect to Allergan and the JUVÉDERM market, this product gets approved, does it become 100% accepted and used exclusively by Allergan, replacing its current dermal filler? Or is it going to be in combination and offering both different products?

而且我不知道你能否透露一下，回顧一下艾爾建和JUVäDERM市場，這個產品獲得批准後，是否會被艾爾建100%接受並獨家使用，取代其目前的真皮填充劑？或者它將結合併提供兩種不同的產品？

Well, Allergan is in charge on the -- they have the market strategy. We are not allowed to talk about it, and that's it.

嗯，艾爾建負責──他們有市場策略。我們不被允許談論它，僅此而已。

Okay. All right. Well, I appreciate your time, guys. Thank you so much.

好的。好的。好吧，我很感謝你們抽出時間，夥計們。太感謝了。

Thank you.

謝謝。

Ben Haynor, Alliance Global Partners.

Ben Haynor，聯盟全球合作夥伴。

Good morning, gentlemen. Thanks for taking the questions, and congrats on the milestone payment from AbbVie. First off for me, I know with AbbVie there was an upfront clinical regulatory commercial milestones associated with it. Are there more clinical milestones or is regulatory the next one that we should be looking at?

早安，先生們。感謝您提出問題，並祝賀艾伯維獲得里程碑付款。首先對我來說，我知道艾伯維有一個與之相關的前期臨床監管商業里程碑。是否還有更多的臨床里程碑或監管是我們應該關注的下一個里程碑？

So that information was not disclosed. I can say that, regarding the dermal filler product, we are expecting additional $26 million in additional milestones, but we cannot refer to what exactly are the milestones.

所以這個訊息沒有被公開。我可以說，關於真皮填充劑產品，我們預計在額外里程碑中額外獲得 2,600 萬美元，但我們無法提及具體的里程碑是什麼。

Okay. So you can't share whether the next one might be of a certain type?

好的。所以你不能透露下一個是否可能屬於某種類型？

Correct.

正確的。

Okay, that's fair enough. I understand. And then just secondly for me on the cross-promotion that you guys have with Stratasys, any initial returns so far? How has that been going, expectations there? Just curious on the bioink side of things and the relationship with Stratasys.

好吧，這很公平。我明白。其次，關於你們與 Stratasys 的交叉推廣，到目前為止有任何初步回報嗎？進展如何，有期望嗎？只是對生物墨水方面以及與 Stratasys 的關係感到好奇。

Hey, can you please repeat the question?

嘿，你能重複一下這個問題嗎？

Sure. I was just wondering on the cross-promotion that you guys are doing with Stratasys, if there have been any, I guess maybe not initial successes there, but how are those conversations going? Any expectations on what that could lead to down the road with Stratasys?

當然。我只是想知道你們與 Stratasys 進行的交叉推廣，如果有的話，我想可能不是最初的成功，但這些對話進行得怎麼樣？對於 Stratasys 的未來發展有何期望？

Okay, I see. So with Stratasys, first of all, we are working with their printer that is called Origin One, which is utilizing a very unique technology for photopolymerization. And we are working together with them in developing a printing process for the breast implant.

好吧，我明白了。因此，對於 Stratasys，我們首先使用他們名為 Origin One 的印表機，該印表機採用了非常獨特的光聚合技術。我們正在與他們合作開發乳房植入物的列印過程。

At this point of time, we are already printing implants of 100 cc with their printer, and we are optimizing the process. And of course, the intention is, this is the first focus of us in this collaboration, is to develop a scalable biofabrication solution for the breast implant, which, later on, can be extended to other tissues and organs, including an automated process.

目前，我們已經使用他們的印表機列印 100 cc 的植入物，並且我們正在優化流程。當然，我們的目的是，這是我們這次合作的第一個重點，是為乳房植入物開發可擴展的生物製造解決方案，隨後可以擴展到其他組織和器官，包括自動化過程。

And regarding the part of the sales of the bioink that you are referring to, this will come in a later stage once they will have the relevant printer in the market. There, we will see the kind of sales that you are asking about.

至於你提到的生物墨水的銷售部分，一旦他們在市場上擁有相關印表機，這將在稍後階段進行。在那裡，我們將看到您所詢問的銷售類型。

Okay. So that's still a little ways off.

好的。所以這還有一點距離。

Right.

正確的。

Okay, understood. Excellent. Well, thanks for taking the questions, gentlemen. And again, congrats on the AbbVie milestone.

好的，明白了。出色的。好的，謝謝您提出問題，先生們。再次恭喜艾伯維取得里程碑。

Thank you.

謝謝。

Thank you, Ben.

謝謝你，本。

I believe that is the last question from our live audience participants, so I'll turn it back to Mr. Rotem for any questions that came in online.

我相信這是現場觀眾提出的最後一個問題，因此我會將網路上提出的任何問題轉回給 Rotem 先生。

Sure. Thank you. So the first question that came online is regarding the cash balance of the company. And does it, the $22 million that we had in the bank as of June 30, include the $10 million from Allergan's milestone achievement or doesn't it?

當然。謝謝。因此，網路上出現的第一個問題是關於公司的現金餘額。截至 6 月 30 日，我們在銀行的 2,200 萬美元是否包括艾爾建里程碑式成就的 1,000 萬美元？

So the $10 million came in July after the date of the balance sheet, so no, the $22 million is not including the $10 million. So at the end of July, the company had above $30 million in cash, which also apply to the cash that we have. And this is relating to another question that came regarding for how long the cash that the company has will last.

所以這 1000 萬美元是在資產負債表日之後的 7 月份到來的，所以不，這 2200 萬美元不包括這 1000 萬美元。因此，到 7 月底，該公司擁有超過 3,000 萬美元的現金，這也適用於我們擁有的現金。這與另一個問題有關，即公司擁有的現金能維持多久。

So if we had last month more than $30 million, and as you know from, if you are taking a look at the historical financial performance, for example, this year, the company was using for operation about $7 million for six months, so you can understand the cash that the company has, we have money for more than at least two years. So this was one question.

因此，如果我們上個月的資金超過 3000 萬美元，正如您所知，如果您查看歷史財務業績，例如今年，該公司六個月的營運費用約為 700 萬美元，那麼您可以理解公司有現金，我們有錢至少兩年以上。所以這是一個問題。

The second one was actually addressed by the other questions that were raised. So it is asking about when will the company have a commercial sales on products and can we give some more details regarding the schedule of the collaboration with Allergan.

第二個問題其實是由提出的其他問題解決的。所以問的是公司什麼時候可以對產品進行商業銷售，我們能否提供更多與艾爾建合作的時間表的細節。

So for the second part, I believe we addressed it. We are disclosing whatever we can about the program with Allergan. This program is four years now, and the milestone achievement is demonstrating the progress of the program.

因此，對於第二部分，我相信我們已經解決了這個問題。我們正在盡我們所能地披露有關艾爾建項目的資訊。該計劃現已實施四年，里程碑式的成就正在展示該計劃的進展。

And regarding commercial sales, the company is selling its bioink and rhCollagen for the development industry. This is an industry that is in development phase. And we never gave a forecast regarding the commercial sales, so we will not do it as well now.

在商業銷售方面，該公司正在為開發行業銷售其生物墨水和 rhCollagen。這是一個正處於發展階段的行業。而且我們從來沒有對商業銷售做出預測，所以我們現在也不會這樣做。

And that was the last question that we received by mail via the system. So that concludes our questions from the audience. So I'll now return it back to Yehiel Tal, CollPlant's Chief Executive Officer, for any closing remarks. Yehiel?

這是我們透過系統透過郵件收到的最後一個問題。聽眾的提問到此結束。現在，我將把它發回給 CollPlant 執行長 Yehiel Tal，讓其結束語。葉希爾？

Yes. Thank you, Eran. As I've stated, we at CollPlant aspire to become the leaders in regenerative medicines, helping people live longer and better and creating improvements in science through our regenerative technologies.

是的。謝謝你，埃蘭。正如我所說，我們 CollPlant 立志成為再生醫學領域的領導者，幫助人們活得更長、活得更好，並透過我們的再生技術推動科學進步。

Our goal is to create better alternatives and options for the future, such as an unlimited supply of spare parts for the human body, including life-saving organs, medical treatment tailored to the individual characteristics of each patient, and drugs developed without the need for animal testing. Our vision is to enable a world with unlimited organ supply, regenerative tissue products, and novel drugs and diagnostics that do not rely on animals.

我們的目標是為未來創造更好的替代方案和選擇，例如無限量供應人體備件，包括挽救生命的器官、針對每個患者個體特徵量身定制的醫療，以及開發無需人工幹預的藥物。動物測驗。我們的願景是讓世界擁有無限的器官供應、再生組織產品以及不依賴動物的新型藥物和診斷方法。

In closing, I want to reiterate our upcoming goals for the remainder of 2023 and through the first half of 2024. We plan to continue to advance development of the paradigm-shifting regenerative dermal and soft tissue filler program with AbbVie, initiate a study in large animals with commercial-sized breast implants to generate additional safety and efficacy data in support of commercialization of this program, announce next steps for the development of the gut-on-a-chip tissue model for drug discovery and personalized treatment of diseases beginning with ulcerative colitis, continue to expand our commercial portfolio of rhCollagen-based bioinks, and finally, form new collaborations with industry leaders to co-develop new medical therapies and applications using our regenerative recombinant human collagen technology.

最後，我想重申我們在2023 年剩餘時間和2024 年上半年的即將到來的目標。我們計劃繼續與艾伯維(AbbVie) 一起推進範式轉變的再生真皮和軟組織填充劑項目的開發，啟動一項大型研究具有商業尺寸乳房植入物的動物，以產生額外的安全性和有效性數據，以支持該計劃的商業化，宣布開發芯片腸道組織模型的後續步驟，用於藥物發現和從潰瘍性病變開始的疾病的個人化治療結腸炎，繼續擴大我們基於rhCollagen 的生物墨水的商業組合，最後，與行業領導者建立新的合作，利用我們的再生重組人類膠原蛋白技術共同開發新的醫療療法和應用。

Thank you, everyone, for your time this morning and for joining us today for today's conference call.

感謝大家今天早上抽出時間參加我們今天的電話會議。

This concludes today's conference call. You may disconnect your lines at this time, and we thank you for your participation.

今天的電話會議到此結束。此時您可以斷開線路，我們感謝您的參與。